ID

33065

Description

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Keywords

Versions (2)
  1. 11/23/18 11/23/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 26, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020

English

Visit 2: Unsolicited Adverse Events

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

text

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Description

Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?

Data type

text

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Visit 2: Unsolicited Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 2 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
text
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
CL Item
Information not availble (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event Form (4)
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